Visual stabilizer on anchor legs of vena cava filter

ABSTRACT

A removable vena cava filter ( 10 ) configured for reduced trauma and enhanced visualization of anchoring hook placement relative to the vessel wall is disclosed. The filter includes a plurality of struts ( 12   a - d ), each having an anchoring hook ( 26 ) and a stop member ( 24 ) proximate the anchoring hook. The stop members are configured to engage the vessel wall to prevent excessive penetration of the anchoring hooks into the vessel wall and to aid in the identification of anchoring hook placement relative to the vessel wall.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is related to and claims the benefit of priority toPCT/US2011/020950, filed Jan. 12, 2011, which application claims thebenefit of U.S. Provisional Application No. 61/294,269, filed on Jan.12, 2010, entitled “Visual Stabilizer on Anchor Legs of Vena CavaFilter,” both of which are incorporated herein by reference.

BACKGROUND OF THE INVENTION

1. Field of Invention

The present invention relates to medical devices. More particularly, theinvention relates to a removable vena cava filter that can bepercutaneously placed in and removed from the vena cava of a patientwith reduced trauma and enhanced visualization of anchoring hookplacement relative to the vena cava wall.

2. Background

Filtering devices that are percutaneously placed in the vena cava havebeen available for over thirty years. A need for filtering devicesarises in trauma patients, orthopedic surgery patients, neurosurgerypatients, or in patients having medical conditions requiring bed rest ornon-movement. During such medical conditions, the need for filteringdevices arises due to the likelihood of thrombosis in the venousperipheral vasculature of patients wherein thrombi break away from thevessel wall, risking downstream embolism or embolization. For example,depending on the size, such thrombi pose a serious risk of pulmonaryembolism wherein blood clots migrate from the peripheral vasculaturethrough the heart and into the lungs.

A filtering device can be deployed in the vena cava of a patient when,for example, anticoagulant therapy is contraindicated or has failed.Typically, filtering devices are permanent implants, each of whichremains implanted in the patient for life, even though the condition ormedical problem that required the device has passed. In more recentyears, filters have been used or considered in preoperative patients andin patients predisposed to thrombosis which places the patient at riskfor pulmonary embolism.

The benefits of a vena cava filter have been well established, butimprovements may be made. For example, filters generally have some typeof anchoring member to anchor the filter to the vena cava wall. Withsuch anchoring members, there is a risk of increased trauma to the venacava wall should the filter be inadvertently and/or improperly moved,thus causing further penetration of the anchoring member into or throughthe vena cava wall.

BRIEF SUMMARY OF THE INVENTION

The present invention generally provides a removable vena cava filterfor capturing thrombi in a blood vessel. In one embodiment, the filterincludes a plurality of struts having a collapsed state for filterretrieval or delivery and an expanded state for engaging with a vesselwall of the blood vessel. The struts have first ends attached togetheralong a longitudinal axis of the filter. The struts extend from thefirst ends to second ends. Each strut includes a proximal portionextending from the first end and a distal portion extending from theproximal portion to the second end. The distal portion of each strutincludes an anchoring hook configured to penetrate the vessel wall and astop member proximate the anchoring hook. The stop member is configuredto engage the vessel wall to prevent further penetration of theanchoring hook into or through the vessel wall and to reduce trauma tothe vessel wall. In addition, the stop member enhances visualization ofthe anchoring hook and its position relative to the vessel wall.

In another embodiment, the removable filter includes a plurality ofstruts having a collapsed state for filter retrieval or delivery and anexpanded state for engaging with a vessel wall of the blood vessel. Eachstrut extends from a first end to a second end. The first ends of thestruts are attached together along a longitudinal axis of the filter.Each strut extends arcuately along the longitudinal axis and includes aproximal portion extending from the first end and a distal portionextending from the proximal portion to the second end. The distalportion of each strut includes an anchoring hook configured to penetratethe vessel wall and a stop member configured to engage the vessel wallto prevent further penetration of the anchoring hook into or through thevessel wall. The stop member is further configured to enhancevisualization of the anchoring hook and its position relative to thevessel wall. The stop member is formed separately from the strut andattached to the strut adjacent the anchoring hook such that the stopmember extends distally from the anchoring hook. The second end of eachstrut thus terminates with the stop member.

In yet another embodiment, the removable filter includes a central axisand a plurality of struts having a collapsed state for filter retrievalor delivery and an expanded state for engaging with a vessel wall of ablood vessel. Each strut extends from a first end to a second end andterminates with an anchoring hook at the second end. The first ends areattached together along the central axis. The anchoring hooks areconfigured to penetrate the vessel wall to anchor the filter to thevessel wall. Each strut includes a stop member disposed proximallyrelative to the anchoring hook. The stop members are configured toengage the vessel wall to prevent further penetration of the anchoringhooks into and through the vessel wall and to reduce trauma to thevessel wall. The stop members are formed of a radiopaque material toenhance visualization of the anchoring hooks and their respectivepositions relative to the vessel wall.

Further aspects, features, and advantages of the invention will becomeapparent from consideration of the following description and theappended claims when taken in connection with the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an illustration of the anatomy of the renal veins, the iliacveins, and the vena cava in which a prior art filter has been deployed;

FIG. 1a is an enlarged view of the prior art filter in circle 1 a ofFIG. 1, depicting an anchoring hook engaged in the vessel wall;

FIG. 2 is a side perspective view of one embodiment of a vena cavafilter of the present invention, shown in an expanded state;

FIG. 3a is an enlarged view of circle 3 a in FIG. 2;

FIGS. 3b-e are enlarged views of a filter leg in accordance withalternative embodiments of the present invention;

FIGS. 4a-e show the anchoring hooks of the filter legs of FIGS. 3a-e ,respectively, penetrating a vessel wall;

FIG. 5 is an enlarged view of circle 5 in FIG. 2;

FIG. 6 is an end view of the filter in FIG. 2 taken along line 6-6;

FIG. 7a is a side view of the filter in FIG. 2 in a collapsed state anddisposed in an introducer tube;

FIG. 7b is an enlarged view of anchoring hooks of the filter in FIG. 2in the collapsed state;

FIG. 8 is a cross-sectional view of a hub of the filter in FIG. 2 takenalong line 8-8; and

FIG. 9 is a cross-sectional view of the vena cava in which the filter ofFIG. 2 has been deployed.

DETAILED DESCRIPTION OF THE INVENTION

The following provides a detailed description of currently preferredembodiments of the present invention. The description is not intended tolimit the invention in any manner, but rather serves to enable thoseskilled in the art to make and use the invention.

Referring now to FIG. 1, a vena cava filter found in the prior art,denoted by reference numeral 100, is implanted in the vena cava 50 forthe purpose of lysing or capturing thrombi carried by the blood flowingthrough the iliac veins 54, 56 toward the heart and into the pulmonaryarteries. As shown, the iliac veins 54, 56 merge at juncture 58 into thevena cava 50. The renal veins 60 from the kidneys 62 join the vena cava50 downstream of juncture 58. The portion of the vena cava 50 betweenthe juncture 58 and the renal veins 60 defines the inferior vena cava 52in which the vena cava filter 100 has been percutaneously deployedthrough one of the femoral veins or one of the jugular veins.

As depicted in FIG. 1, the prior art filter 100 includes a plurality ofprimary struts 112 which terminate with an anchoring hook 126 foranchoring the filter 100 in the vena cava wall 51. FIG. 1a shows ananchoring hook 126 piercing the vena cava wall 51. As the anchoring hook126 anchors to the vena cava wall 51, the anchoring hook 126 makes asmall cut or pokes a small hole in the vena cava wall 51. Movement ofthe filter 100 can cause the anchoring hook 126 to penetrate furtherinto and through the vena cava wall 51 via the small cut or hole,causing increased trauma to the vena cava wall 51.

Embodiments of the present invention provide an improved filter havingstop members configured to prevent excessive penetration of theanchoring hooks into and through the vena cava wall. Moreover, the stopmembers of the improved filter aid in visualization of filter placementand, specifically, identification of placement of the anchoring hooksrelative to the vena cava wall.

FIG. 2 illustrates a vena cava filter 10 in accordance with a preferredembodiment of the present invention. As shown in FIG. 2, the filter 10is in an expanded state and comprises four filter legs or primary struts12 a-d, each having first ends 14 that emanate from a hub 11. The hub 11attaches by crimping the first ends 14 of the primary struts 12 a-dtogether along a center point A in a compact bundle along a central orlongitudinal axis X of the filter. The hub 11 has a minimal diameter forthe size of wire used to form the primary struts 12 a-d.

Preferably, the primary struts 12 a-d are formed from a spring materialor a superelastic material, including but not limited to stainlesssteel, cobalt-chromium-nickel-molybdenum-iron alloy, cobalt-chromealloy, nitinol, or any other suitable material that will result in aself-opening or self-expanding filter. In this embodiment, the primarystruts 12 a-d are preferably formed from wire having a round or nearround cross-section with a diameter of at least about 0.015 inches. Ofcourse, it is not necessary that the primary struts have a roundcross-section. For example, the primary struts 12 a-d could take on anyshape with rounded edges to maintain non-turbulent blood flowtherethrough.

As shown in FIG. 2, each primary strut 12 a-d extends from the first end14 to a second end 15 and includes an arcuate segment 16 having a softS-shape. Each arcuate segment 16 is formed with a first curved proximalportion 20 that is configured to softly bend away from the longitudinalaxis X of the filter 10 and a second curved distal portion 23 that isconfigured to softly bend toward the longitudinal axis of the filter 10.Due to the soft bends of each arcuate segment 16, a prominence or apoint of inflection on the primary strut 12 a-d is substantially avoidedto aid in non-traumatically engaging the vena cava or vessel wall 51. Asexplained in more detail below with reference to FIGS. 5 and 6, thefirst curved proximal portion 20 of each primary strut 12 a-d has anaxial or circumferential bend 25 a-d.

As illustrated in FIG. 2, each of the primary struts 12 a-d is an anchorleg, including an anchoring hook 26 at the second end 15 that willanchor in the vessel wall 51 when the filter 10 is deployed at adelivery location in the blood vessel. The primary struts 12 a-d areconfigured to move between the expanded state for engaging the anchoringhooks 26 with the blood vessel and the collapsed state for filterretrieval or delivery. In the expanded state, each arcuate segment 16extends arcuately along a longitudinal X (as shown in FIG. 2) andsubstantially linearly along a diametric plane (as shown in FIG. 6) toavoid entanglement with other primary struts 12 a-d.

As discussed in greater detail below, the soft bends of each arcuatesegment 16 allow each primary strut 12 a-d to cross another primarystrut 12 a-d along the longitudinal axis X in the collapsed state suchthat each anchoring hook 26 faces the longitudinal axis X for filterretrieval or delivery.

When the filter 10 is deployed in a blood vessel 52, the anchoring hooks26 at the second ends 15 of the primary struts 12 a-d engage the innerwall 51 of the blood vessel 52 to define a first axial portion to securethe filter 10 in the blood vessel 52. The anchoring hooks 26 prevent thefilter 10 from migrating from the delivery location in the blood vessel52 where it has been deposited. The primary struts 12 a-d are shaped anddimensioned such that, when the filter 10 is freely expanded, the filter10 has a diameter of between about 25 mm and 45 mm and a length ofbetween about 3 cm and 7 cm. For example, the filter 10 may have adiameter of about 35 mm and a length of about 5 cm. The primary struts12 a-d have sufficient spring strength that when the filter 10 isdeployed the anchoring hooks 26 will anchor into the vessel wall 51.

Referring to FIGS. 3a and 4a , the second curved distal portion 23 ofeach of the primary struts 12 a-d includes a stabilizer, or stop member,24 in close proximity to the anchoring hook 26. As provided above, theanchoring hooks 26 prevent migration of the filter 10 within the bloodvessel. The anchoring hooks 26 accomplish this by piercing a small hole,or making a small cut, in the vessel wall 51 to penetrate the vesselwall 51. The stop members 24 are configured to prevent further,excessive penetration of the anchoring hook 26 through the hole or cutin the vessel wall 51. In addition, the stop members 24 provide enhancedvisualization of the anchoring hooks 26 and their respective positionsrelative to the vessel wall 51.

In this embodiment, each stop member 24 is disposed distally relative tothe anchoring hook 26 such that the second end 15 of each primary strut12 a-d terminates with the stop member 24. Each stop member 24 is formedseparately from each primary strut 12 a-d and is attached to the secondend 15 of each primary strut 12 a-d at the curved portion of theanchoring hook 26. Preferably, the stop member 24 is welded to eachprimary strut 12 a-d, although the stop member 24 may be attached to theprimary strut 12 a-d by any other suitable attachment means, includingbut not limited to soldering or gluing. In this embodiment, the lengthof the stop member 24 (i.e., the distance the stop member 24 extendsfrom the anchoring hook 26) is between about 0.5 mm and about 10.0 mm.The diameter of the stop member 24 is preferably about the same diameterof the primary strut 12 a-d, give or take about 0.2 mm. In thisembodiment, the distal tip 27 of the stop member 24 is rounded so thatit is atraumatic to the vessel wall 51.

As illustrated in FIG. 4a , in the event external compression of thevessel 52, or movement of the filter 10, causes the anchoring hooks 26to move toward further penetration into the vessel wall 51, the stopmembers 24 are configured to engage or abut the vessel wall 51 toprevent further penetration of the anchoring hooks 26. In thisembodiment, the stop member 24 is atraumatic and thus does not piercethe vessel wall 51. Rather, as shown in FIG. 4a , the stop member 24pushes against the vessel wall 51, thereby preventing the anchoring hook26 from further penetrating into the vessel wall 51. Accordingly, eachstop member 24 is configured to reduce the likelihood of increasedtrauma to the vessel wall 51 caused by further penetration of theadjacent anchoring hook 26 into or through the vessel wall 51.

Additionally, the stop members 24 provide physicians with the ability toidentify placement of the anchoring hooks 26 relative to the vena cavawall 51. The stop members 24 are thus preferably formed from a differentmaterial than the primary struts 12 a-d, most preferably a radiopaquematerial, such as platinum, palladium or any suitable radiopaquematerial known in the art.

Moreover, the stop members 24 preferably include a plurality of dimples31 formed on an outer surface thereof to further enhance visualizationof anchoring hook 26 placement, not only under x-ray examination, butunder ultrasound examination as well. The dimples 31 provide the outersurface of the stop members 24 with the desired surface irregularitiescapable of reflecting ultrasound waves. In a preferred embodiment, thedimples 31 are small, circular indentations impressed upon the outersurface of the stop members 24 by any suitable means known in the artand have a diameter of approximately 0.1 mm and a depth of approximately0.01 mm. They are preferably distributed over the entire outer surfaceof the stop members 24. The dimples 31 may be formed on the stop members24 before or after attachment thereof to the primary struts 12. It isalso within the scope of the present invention for a plurality ofdimples 31 to be formed on a portion of the outer surface of the primarystruts 12 adjacent the anchoring hook 26, as shown in FIGS. 3a and 4a ,to further enhance visualization of the filter 10 via ultrasound.

FIGS. 3b and 4b depict an alternative embodiment of a primary strut 212of a filter 210 in accordance with the teachings of the presentinvention and having a description similar to that of FIGS. 3a and 4a ,and in which similar components are denoted by similar referencenumerals increased by 200. In this embodiment, the stop member 224 isdisposed proximally relative to the anchoring hook 226 such that thesecond end 215 terminates with the anchoring hook 226. The stop member224 projects radially outward from the primary strut 212 to provide aportion of the primary strut 212 having an increased circumferentialarea.

As shown in FIGS. 3b and 4b , the stop member 224 is a conical annularband having an apex region 224 a and a base 224 b. The stop member 224has an inner diameter sized and configured to receive the primary strut212. In this embodiment, the primary strut 212 has an outer diameter d₁,the base 224 b of the stop member 224 has an outer diameter d₂ greaterthan the outer diameter d₁ of the primary strut 212, and the apex region224 a of the stop member 224 has an outer diameter d₃ smaller than theouter diameter d₂ of the base 224 b and slightly larger than outerdiameter d₁ of the primary strut 212. As illustrated in FIG. 3b , theouter diameter of the conical annular stop member 224 tapers proximallyfrom the base 224 b to the apex region 224 a.

As previously stated, the stop member 224 provides a portion of eachprimary strut 212 with an increased circumferential area. As depicted inFIGS. 3b and 4b , the anchoring hook 226 is curved in a direction towardthe hub and the stop member 224 extends in a direction away from thehub, i.e., the stop member 224 radially expands from the apex region 224a to the base 224 b. In this embodiment, each stop member 224 is formedseparately from the primary strut 212 and is attached to the distalportion 223 of each primary strut 212 proximally relative to theanchoring hook 226. In one example, the annular stop member 224 may beslid over the second end 215 of the primary strut 212 prior to formingthe anchoring hook 226 at the terminal end of the primary strut 212.Once in a desired position, the stop member 224 may be attached to theprimary strut 212 by any suitable means known in the art, including butnot limited to crimping, soldering, gluing, or laser welding.Thereafter, the anchoring hook 226 may be formed by curving the terminalend of the primary strut 212 in a direction toward the hub. Preferably,the stop member 224 is disposed between about 2 mm and about 10 mm, andmost preferably about 5 mm, from the anchoring hook 226.

As illustrated in FIG. 4b , in the event external compression of thevessel 52, or movement of the filter 210, causes the anchoring hooks 226to move toward further penetration into the vessel wall 51, the oppositeorientation of the anchoring hook 226 and corresponding stop member 224of each primary strut 212 is configured to prevent further penetrationof the anchoring hooks 226 into the vessel wall 51. Moreover, theincreased circumferential area of the primary strut 212, i.e., the stopmember 224, is configured to engage or abut the vessel wall 51 toprevent further penetration of the anchoring hooks 226. Preferably, asshown in FIG. 4b , the base 224 b of the stop member 224 pushes againstthe vessel wall 51, thereby preventing the anchoring hook 226 fromfurther penetrating into the vessel wall 51. Accordingly, the stopmember 224 is configured to reduce the likelihood of increased trauma tothe vessel wall 51 caused by further penetration of the anchoring hook226 into the vessel wall 51.

FIGS. 3c and 4c depict an alternative embodiment of a primary strut 312of a filter 310 in accordance with the teachings of the presentinvention and having a description similar to that of FIGS. 3a and 4a ,and in which similar components are denoted by similar referencenumerals increased by 300. In this embodiment, the stop member 324 isdisposed proximally relative to the anchoring hook 326 such that thesecond end 315 terminates with the anchoring hook 326. The stop member324 projects radially outward from the primary strut 312 to provide aportion of the primary strut 312 with an increased circumferential area.As shown in FIGS. 3c and 4c , the stop member 324 is an annular bandhaving a cylindrical ring portion 329 and a barb extension 328 formedunitarily therewith. The stop member 324 has an inner diameter sized andconfigured to receive the primary strut 312 and the barb extension 328extends radially from the primary strut 312 in a direction away from thelongitudinal axis X when the filter 310 is in the expanded state. Inthis embodiment, the primary strut 312 has an outer diameter d₁ and thebarb extension 328 extending radially from the primary strut 312 definesan outer diameter d₄ greater than the outer diameter d₁.

As provided above, the stop member 324 includes a barb extension 328,which defines an increased outer diameter d₁, and thus provides aportion of each primary strut 312 with an increased circumferentialarea. As shown in FIGS. 3c and 4c , the anchoring hook 326 is curved ina direction toward the hub and the barb extension 328 extends in adirection away from the hub. In this embodiment, each stop member 324 ispreferably formed separately from the primary strut 312 and is attachedto the distal portion 323 of each primary strut 312 proximally relativeto the anchoring hook 326. In one example, the annular stop member 324may be slid over the second end 315 of the primary strut 312 prior toforming the anchoring hook 326 at the terminal end of the primary strut312. Once in a desired position, the stop member 324 may be attached tothe primary strut 312 by any suitable means known in the art, includingbut not limited to crimping, soldering, gluing, or laser welding.Thereafter, the anchoring hook 326 may be formed by curving the terminalend of the primary strut 312 in a direction toward the hub. Preferably,the stop member 324 is disposed between about 2 mm and about 10 mm, andmost preferably about 5 mm, from the anchoring hook 326.

As illustrated in FIG. 4c , in the event external compression of thevessel 52, or movement of the filter 310, causes the anchoring hooks 326to move toward further penetration into the vessel wall 51, the oppositeorientation of the anchoring hook 326 and corresponding barb extension328 of each primary strut 312 is configured to prevent furtherpenetration of the anchoring hooks 326 into the vessel wall. Moreover,the increased circumferential area of the primary strut 312, i.e., thestop member 324, is configured to engage or abut the vessel wall 51 toprevent further penetration of the anchoring hooks 326. Preferably, asshown in FIG. 4c , the barb extension 328 of the stop member 324 pushesagainst the vessel wall 51, thereby preventing the anchoring hook 326from further penetrating into the vessel wall 51. Accordingly, the stopmember 324 is configured to reduce the likelihood of increased trauma tothe vessel wall 51 caused by further penetration of the anchoring hook326 into the vessel wall 51.

In this embodiment, the barb extension 328 preferably has a sharpenedtip which engages or anchors into the vessel wall 51 to prevent furtherpenetration of the anchoring hook 326. Preferably, the sharpened tipfunctions as an additional hooking member. As opposed to a round-shapedstop member, the sharpened tip of the barb extension 328 is able topierce the wall, thus providing a higher resistance against the vesselwall 51 to prevent the strut 312 from penetrating further.

FIGS. 3d and 4d depict an alternative embodiment of a primary strut 412of a filter 410 in accordance with the teachings of the presentinvention and having a description similar to that of FIGS. 3a and 4a ,and in which similar components are denoted by similar referencenumerals increased by 400. In this embodiment, the stop member 424 isdisposed proximally relative to the anchoring hook 426 such that thesecond end 415 terminates with the anchoring hook 426. The stop member424 projects radially outward from the primary strut 412 to provide aportion of the primary strut 412 with an increased circumferential area.As shown in FIGS. 3d and 4d , the stop member 424 is a bent or curvedwire filament having a tangential portion 431 tangential to and attachedto the primary strut 412 and a projecting portion 433 projectingradially outward from the primary strut 412, i.e., in a direction awayfrom the longitudinal axis X, when the filter 410 is in the expandedstate.

In this embodiment, the primary strut 412 has an outer diameter d₁ andthe projecting portion 433 of the stop member 424 extending radiallyfrom the primary strut 412 defines an outer diameter d₅ greater than theouter diameter d₁. Preferably, the projecting portion 433 is bent at anangle of about 45 degrees with respect to an axis defined by the distalportion 423 of the primary strut 412, as illustrated in FIG. 3d . Thedifference between d₅ and d₁ is preferably about 1 mm, i.e., theprojecting portion 433 projects about 1 mm from the primary strut 412.

As previously stated, the stop member 424 defines an increased outerdiameter d₅, and thus provides a portion of each primary strut 412 withan increased circumferential area. As shown in FIGS. 3d and 4d , theanchoring hook 426 is curved in a direction toward the hub and theprojecting portion 433 of the stop member 424 extends in a directionaway from the hub. In this embodiment, each stop member 424 is formedseparately from the primary strut 412 and is attached to the distalportion 423 of each primary strut 412 proximally relative to theanchoring hook 426. In one example, the tangential portion 431 of thestop member 424 is attached to the primary strut 412 by any suitablemeans known in the art, including but not limited to crimping,soldering, gluing, or laser welding. Preferably, the stop member 424 isdisposed between about 2 mm and about 10 mm, and most preferably about 5mm, from the anchoring hook 426.

As illustrated in FIG. 4d , in the event external compression of thevessel 52, or movement of the filter 410, causes the anchoring hooks 426to move toward further penetration into the vessel wall 51, the oppositeorientation of the anchoring hook 426 and corresponding projectingportion 433 of the stop member 424 of each primary strut 412 isconfigured to prevent further penetration of the anchoring hooks 426into the vessel wall. Moreover, the increased circumferential area ofthe primary strut 412, i.e., the stop member 424, is configured toengage or abut the vessel wall 51 to prevent further penetration of theanchoring hooks 426. Preferably, as shown in FIG. 4d , the projectingportion 433 of the stop member 424 pushes against the vessel wall 51,thereby preventing the anchoring hook 426 from further penetrating intothe vessel wall 51. Accordingly, the stop member 424 is configured toreduce the likelihood of increased trauma to the vessel wall 51 causedby further penetration of the anchoring hook 426 into the vessel wall51.

In this embodiment, the projecting portion 433 may have a sharpened tipwhich engages or anchors into the vessel wall 51 to prevent furtherpenetration of the anchoring hook 426. Preferably, the sharpened tipfunctions as an additional hooking member. As opposed to a round-shapedstop member, the sharpened tip of the projecting portion 433 is able topierce the wall, thus providing a higher resistance against the vesselwall 51 to prevent the strut 412 from penetrating further.

FIGS. 3e and 4e depict an alternative embodiment of a primary strut 512of a filter 510 in accordance with the teachings of the presentinvention and having a description similar to that of FIGS. 3a and 4a ,and in which similar components are denoted by similar referencenumerals increased by 500. In this embodiment, the stop member 524 isdisposed proximally relative to the anchoring hook 526 such that thesecond end 515 terminates with the anchoring hook 526. The stop member524 projects radially inward from the primary strut 512, as opposed toprojecting radially outward in the embodiment of FIGS. 3d and 4d , toprovide a portion of the primary strut 512 with an increasedcircumferential area. As shown in FIGS. 3e and 4e , the stop member 524is a bent or curved wire filament having a tangential portion 531tangential to and attached to the primary strut 512 and a projectingportion 533 projecting radially inward from the primary strut 412, i.e.,in a direction toward the longitudinal axis X, when the filter 510 is inthe expanded state.

In this embodiment, the primary strut 512 has an outer diameter d₁ andthe projecting portion 533 of the stop member 524 extending radiallyfrom the primary strut 512 defines an outer diameter d₆ greater than theouter diameter d₁. Preferably, the projecting portion 533 is bent at anangle of about 45 degrees with respect to an axis defined by the distalportion 523 of the primary strut 512, as illustrated in FIG. 3e . Thedifference between d₆ and d₁ is preferably about 1 mm, i.e., theprojecting portion 533 projects about 1 mm from the primary strut 512.

As previously stated, the stop member 524 defines an increased outerdiameter d₆, and thus provides a portion of each primary strut 512 withan increased circumferential area. As shown in FIGS. 3e and 4e , theanchoring hook 526 is curved in a direction toward the hub and theprojecting portion 533 of the stop member 524 extends in a directionaway from the hub. In this embodiment, each stop member 524 is formedseparately from the primary strut 512 and is attached to the distalportion 523 of each primary strut 512 proximally relative to theanchoring hook 526. In one example, the tangential portion 531 of thestop member 524 is attached to the primary strut 512 by any suitablemeans known in the art, including but not limited to crimping,soldering, gluing, or laser welding. Preferably, the stop member 524 isdisposed between about 2 mm and about 10 mm, and most preferably about 5mm, from the anchoring hook 526.

As illustrated in FIG. 4e , in the event external compression of thevessel 52, or movement of the filter 510, causes the anchoring hooks 526to move toward further penetration into the vessel wall 51, the oppositeorientation of the anchoring hook 526 and corresponding projectingportion 533 of the stop member 524 of each primary strut 512 isconfigured to prevent further penetration of the anchoring hooks 526into the vessel wall. Moreover, the increased circumferential area ofthe primary strut 512, i.e., the stop member 524, is configured toengage or abut the vessel wall 51 to prevent further penetration of theanchoring hooks 526.

Preferably, as shown in FIG. 4e , the backside of the projecting portion533 of the stop member 524, rather than the tip of the projectingportion 433 of the stop member 424 in FIG. 4d , pushes against thevessel wall 51, thereby preventing the anchoring hook 526 from furtherpenetrating into the vessel wall 51. As shown in FIG. 4e , the backsideof the projecting portion 533 is substantially tangent to the vesselwall 51, i.e., substantially the entire length l of the projectingportion 533 abuts the vessel wall 51, providing a larger contact areaconfigured to engage the vessel wall 51, and thus a higher resistance toprevent further penetration by the anchoring hooks 526. Accordingly, thestop member 524 is configured to reduce the likelihood of increasedtrauma to the vessel wall 51 caused by further penetration of theanchoring hook 526 into the vessel wall 51.

While the stop members of FIGS. 3a-e are preferably a radiopaquematerial and formed separately from respective primary struts, the stopmembers 424, 524 in FIGS. 3d and 3e may be formed integrally, i.e.,unitarily, with respective primary struts 412, 512 by laser cutting aseries of slits in the primary struts 412, 512 and bending the portionof the primary struts 412, 512 defined by the slits to resemble theprojecting portion 433, 533 of the separate wire filament stop member424, 524 discussed above.

It is noted that the anchoring hooks and stop members shown anddescribed with respect to FIGS. 3a-e may be incorporated withalternative filter designs, including but not limited to the filterdescribed in U.S. Pat. No. 5,133,733 to Rasmussen et al., the entirecontents of which are incorporated herein by reference.

As shown in FIG. 3a , each primary strut 12 a-d preferably includes adistal bend 43 formed thereon and extending outwardly radially from thelongitudinal axis X. In this embodiment, the distal bend 43 may extendoutwardly at an angle θ between about 0.5 degree and 2 degrees,preferably 1 degree. The distal bend 43 may be situated at a distancefrom the anchoring hook 26, which is arranged at the end of asubstantially straight strut segment. The distal bend 43 may have alength of between about 1 and 7 mm, preferably between about 2 and 4 mm.The distal bend 43 allows the filter 10 to filter thrombi effectively ata smaller inside diameter of a blood vessel than otherwise would bepossible while maintaining the ability to collapse for delivery orretrieval. Further, the distal bend 43 provides for a more firmengagement of the anchoring hook 26 at the vessel wall. At theengagement of the anchoring hook 26 with the vessel wall, the primarystruts 12 a-d will urge the vessel wall outwards, whereas the vesselwall will urge the primary struts 12 a-d inwards toward the longitudinalaxis X of the filter 10. It is noted that any of the alternativeembodiments illustrated in FIGS. 3b-d may also include such a distalbend. In a preferred embodiment, the anchoring hooks 26 are angled bybetween about 50 and 80 degrees with respect to the last segment of theprimary strut 12 a-d, preferably between about 50 and 60 degrees.

As illustrated in FIGS. 5 and 6, each primary strut 12 a-d includes arespective axial bend 25 a-d. As shown in FIG. 6, each primary strut 12a-d includes a first end 14 which emanates from within the hub 11 and asection 13 a-d which extends linearly along a diametric plane betweenthe first end 14 and the axial bend 25 a-d. The axial bends 25 a-d ofthe respective primary struts 12 a-d result in each primary strut 12 a-dbeing angled by an angle α from a plane defined by the longitudinal axisX and a point along the section 13 a-d of that particular primary strut12 a-d. For example, referring to FIGS. 5 and 6, the axial bend 25 a ofthe primary strut 12 a is angled from the plane P by an angle α. Theplane P is defined by the longitudinal axis X and a point along thesection 13 a that extends between the first end 14 of the primary strut12 a and the axial bend 25 a.

Each proximal portion 20 of each primary strut 12 a-d has an axial bend25 a-d formed thereon relative to the longitudinal axis X of the filter10 and the first end 14, or any point along the section 13 a-d, of therespective primary strut 12 a-d such that the primary struts 12 a-dmaintain continuous consistent orientation together when moving betweenthe opened and closed configurations. Thus, as the filter 10 movesbetween the opened and closed configuration, the primary struts 12 a-dmaintain a relatively uniform or relatively symmetrical arrangementrelative to an end view of the filter. The axial bends 25 a-d cause theprimary struts 12 a-d to close and open relatively consistently,lessening the chance of entanglement. For example (see end view in FIG.6), the relative arrangement of the primary struts 12 a-d is maintained,avoiding crossing over of primary struts 12 a-d and thus lesseningentanglement thereof.

Referring to FIG. 6, the primary struts 12 a-d extend substantiallylinearly along a diametric plane. However, the axial bend 25 a-d on thefirst curved proximal portion 20 of each primary strut 12 a-d results ineach primary strut 12 a-d extending linearly along a diametric planefrom the first end 14 to just before the axial bend 25 a-d and from justafter the axial bend 25 a-d to the second end 15. Thus, the term“substantially linearly,” as opposed to merely “linearly,” takes intoaccount this slight axial bend 25 a-d on each of the respective primarystruts 12 a-d. While the primary struts 12 a-d do not extend completelylinearly along a diametric plane due to the slight axial bends 25 a-d,they do not extend helically. It is noted that the axial bends 25 a-dillustrated in FIG. 6 have been exaggerated for illustration purposes,but may not be so obvious when viewed with the naked eye.

A pair of opposed primary struts, e.g., 12 a and 12 c in FIG. 6, may beoffset by bending the struts 12 a and 12 c by between about 0.5 degreeand 2 degrees relative to plane P to allow the pair of struts 12 a and12 c to cross each other relative to the longitudinal axis X. In thisembodiment, as best illustrated in FIGS. 5 and 6, the opposed first ends14 and sections 13 a and 13 c of respective primary struts 12 a and 12 care arranged parallel to one another. Accordingly, the axial bends 25 a,25 c are angled with respect to the same plane, plane P, defined by thelongitudinal axis X and a point along the section 13 a of primary strut12 a and a point along the section 13 c of the primary strut 12 c.

The same can be said for the pair of opposed primary struts 12 b and 12d. As illustrated in FIGS. 5 and 6, the opposed primary struts 12 b and12 d are arranged parallel to one another. Accordingly, the axial bends25 b, 25 d are angled with respect to the same plane, plane P′, definedby the longitudinal axis X and a point along the section 13 b of theprimary strut 12 b and a point along the section 13 d of the primarystrut 12 d. By the offset, the portion of each primary strut 12 a-dextending between the respective axial bend 25 a-d and the second end ofthe strut 12 a-d is substantially parallel to the corresponding portionof the opposed primary strut 12 a-d.

The axial bends 25 a-d cause the primary struts 12 a-d to beconsistently oriented together relative to the longitudinal axis X ineach occasion the filter 10 is collapsed in the closed state. Thus, whenthe filter 10 is loaded in its collapsed configuration and deployed in abody vessel to its expanded configuration, the struts 12 a-d expandconsistently radially outwardly and remain in relatively the sameorientation or arrangement together. As a result, the risk ofentanglement of the struts is reduced.

The angle of each axial bend 25 a-d may range between about 0.5 and 5°.As the primary struts 12 a-d move between the closed state and theexpanded state of the filter 10, the second curved distal portions 23move consistently radially, in a rotating fashion, from the longitudinalaxis X toward the vessel wall. The rotating radial movement of thesecond curved distal portions 23 aid in reducing the risk ofentanglement of the primary struts 12 a-d.

As best illustrated in FIGS. 2 and 6, the filter 10 includes a pluralityof secondary struts 30 having connected ends 32 attached that alsoemanate from hub 11. Hub 11 attaches by crimping the connected ends 32,along the center point A, of the secondary struts 30 together with theprimary struts 12 a-d. In this embodiment, each primary strut 12 a-d hastwo secondary struts 30 in side-by-side relationship with the primarystrut 12 a-d. The secondary struts 30 extend from the connected ends 32to free ends 34 to centralize the filter 10 in the expanded state in theblood vessel. Preferably, the secondary struts 30 terminate with thefree end 34 and without an anchoring hook or a stop member. As shown,each secondary strut 30 extends arcuately along a longitudinal plane andlinearly along a diametric plane (see end view in FIG. 6) from theconnected end 32 to the free end 34, i.e., the secondary struts 30 donot extend helically.

The secondary struts 30 may be made from the same type of material asthe primary struts 12 a-d. However, the secondary struts 30 may have asmaller diameter, e.g., at least about 0.012 inches, than the primarystruts 12 a-d. In this embodiment, each of the secondary struts 30 isformed of a first arc 40 and a second arc 42. As shown in FIG. 2, thefirst arc 40 extends from the connected end 32 away from thelongitudinal axis X and the second arc 42 extends from the first arc 40towards the longitudinal axis X. As shown, two secondary struts 30 arelocated on each side of one primary strut 12 a-d to form a part of anetting configuration of the filter 10. The hub 11 is preferably made ofthe same material as the primary struts and secondary struts to minimizethe possibility of galvanic corrosion or molecular changes in thematerial due to welding.

FIG. 6 illustrates the netting pattern including primary struts 12 a-dand secondary struts 30 independently spaced substantially equally attheir respective planes. For example, the secondary struts 30 may bespaced equally relative to the other secondary struts 30 and the primarystruts 12 a-d may be spaced equally relative to the other primary struts12 a-d. As a result, the netting pattern in this embodiment shown by theend view of the filter 10 in FIG. 2 (taken along line 6-6) will haveuneven or unequal spacing between the primary struts 12 a-d andsecondary struts 30. However, it is to be understood that the primaryand secondary struts 12 a-d and 30 may be arranged in any other suitablemanner as desired.

When freely expanded, free ends 34 of the secondary struts 30 willexpand radially outwardly to a diameter of about 25 mm to 45 mm. Forexample, the secondary struts 30 may expand radially outwardly to adiameter of between about 35 mm and 45 mm. The second arcs 42 of thefree ends 34 engage the wall 51 of a blood vessel 52 to define a secondaxial plane where the vessel wall 51 is engaged. The secondary struts 30function to stabilize the position of the filter 10 about the center ofthe blood vessel 52 in which it is deployed. As a result, the filter 10has two layers or planes of struts longitudinally engaging the vesselwall 51 of the blood vessel 52. The length of the filter 10 ispreferably defined by the length of a primary strut 12 a-d.

Furthermore, the diameter of the hub 11 is defined by the size of abundle containing the primary struts 12 a-d and secondary struts 30. Inthis embodiment, the eight secondary struts 30 minimally add to thediameter of the hub 11 or the overall length of the filter 10, due tothe reduced diameter of each secondary strut 30. This is accomplishedwhile maintaining the filter 10 in a centered attitude relative to thevessel wall 51 and formed as a part of the netting configuration of thefilter 10. As shown, removal hook 46 extends from hub 11 oppositeprimary and secondary struts 12 a-d and 30.

In this embodiment, each arcuate segment 16 has a thickness of at leastabout 0.015 inch and a tensile strength of between about 285,000 poundsper square inch (psi) and 330,000 psi. Each anchoring hook 26 isintegral with the arcuate segment 16 and has the thickness and thetensile strength of the arcuate segment. Each secondary strut 30 has athickness of at least about 0.012 inch and a tensile strength of betweenabout 285,000 psi and 330,000 psi.

FIG. 7a illustrates the filter 10 in a collapsed state disposed in adelivery/retrieval tube or sheath 94 for delivery or retrieval. Asshown, the filter 10 has primary struts 12 a-d, each of which is formedwith an axial bend 25 a-d for consistent orientation and shaped tocooperate with another primary strut 12 a-d along the longitudinal axisX. As a result, shown in the collapsed state in FIGS. 7a and 7b , theanchoring hooks 26 are configured to be inverted or be inwardlypositioned along the longitudinal axis X away from the inner wall 95 ofthe delivery/retrieval sheath 94 and the blood vessel walls forretrieval/delivery of the filter 10. This inverted or inwardly facingconfiguration of the anchoring hooks 26 allows for simplified deliveryand retrieval of filter 10. For example, a concern that the anchoringhooks 26 in the collapsed state may scrape, scratch, or tear the innerwall of a delivery/retrieval tube is eliminated, since the filter 10 ofthe present invention is shaped to have the anchoring hooks 26 inwardlyface each other in the collapsed state. In fact, a set of inner andouter delivery/retrieval sheaths may be eliminated during the deliveryor retrieval of the filter 10 through the jugular or femoral vein.Rather, merely one delivery/retrieval tube with a loop snare mechanismmay be used to retrieve the filter 10 of the present invention.

With respect to the embodiments of FIGS. 3b-d , the anchoring hooks 226,326, and 426 are oriented opposite of the respective stop members 224,324, and 424 such that the anchoring hooks 226, 326, and 426 are curvedin a direction toward the hub 11 and toward the respective stop members224, 324, and 424, and the stop members 224, 324, and 424 extend in adirection away from the hub 11 and toward the respective anchoring hooks226, 326, and 426. Accordingly, in the collapsed state, the barbextension 328 of the stop member 324 in FIG. 3c and the projectingportion 433 of the stop member 424 in FIG. 3d are configured to beinverted or be inwardly positioned along the longitudinal axis X awayfrom the inner wall 95 of the delivery/retrieval sheath 94 and the bloodvessel walls for retrieval/delivery of the respective filters 310 and410.

Moreover, as shown in FIGS. 7a and 7b in the collapsed state, eachprimary strut 12 a-d is configured to cooperate with another primarystrut 12 a-d along the longitudinal axis X such that the arcuatesegments 16, first curved proximal portions 20 or second curved distalportions 23, occupy a first diameter D₁. In this embodiment, the firstdiameter is greater than a second diameter D₂ occupied by the anchoringhooks 26 for filter retrieval or delivery. It has been found that thefirst diameter of the arcuate segments 16 serves to clear a path ofretrieval, reducing radial force from the sheath or blood vessel on theanchoring hooks 26 during removal of the filter 10 from a patient.Reducing the radial force on the anchoring hooks 26 assists inpreventing the anchoring hooks 26 from scraping, scratching, or tearingthe inner wall of a sheath during removal of the filter 10 from apatient.

In this embodiment of the present invention, it is to be noted that thefilter 10 may be delivered or retrieved by any suitable introducer(delivery or retrieval) sheath. However, it is preferred that theintroducer sheath has an inside diameter of between about 4.5 French and16 French, and more preferably between about 6.5 French and 14 French.

FIG. 8 illustrates a cross-sectional view of the filter 10 of FIG. 2 athub 11. As shown, the hub 11 houses a bundle of first ends 14 of thefour primary struts 12 a-d and connected ends 32 of secondary struts 30.FIG. 8 further depicts the configurations of the primary and secondarystruts 12 a-d and 30. In this embodiment, the primary struts 12 a-d arespaced between two secondary struts 30. Of course, the primary struts 12a-d may be spaced between any other suitably desired number of secondarystruts 30 without falling beyond the scope or spirit of the presentinvention.

FIG. 9 illustrates the filter 10 fully expanded after being deployed ina blood vessel, for example, the inferior vena cava 52. As shown, theinferior vena cava 52 has been broken away so that the filter 10 can beseen. The direction of the blood flow BF is indicated in FIG. 9, by thearrow that is labeled BF. The anchoring hooks 26 at the ends of theprimary struts 12 a-d are shown as being anchored in the inner lining ofthe inferior vena cava 52. The anchoring hooks 26 include barbs 29 that,in one embodiment, project toward the hub 11 of the filter. The barbs 29function to retain the filter 10 in the location of deployment.

The spring biased configuration of the primary struts 12 a-d furthercauses the anchoring hooks 26 to engage the vessel wall and anchor thefilter at the location of deployment. After initial deployment, thepressure of the blood flow on the filter 10 contributes in maintainingthe barbs 29 anchored in the inner lining of the inferior vena cava 52.As seen in FIG. 9, the second arcs 42 of secondary struts 30 also have aspring biased configuration to engage with the vessel wall.

As seen in FIG. 9, the hub 11 and removal hook 46 are positioneddownstream from the location at which the anchoring hooks 26 areanchored in the vessel. When captured by the struts 12 a-d and 30,thrombi remains lodged in the filter. The filter 10 along with thethrombi may then be percutaneously removed from the vena cava. When thefilter 10 is to be removed, the removal hook 46 is preferably grasped bya retrieval instrument that is percutaneously introduced in the venacava in the direction of removal hook 16 first.

Although the embodiments of this invention have been disclosed as beingconstructed from wire having a round cross section, it could also be cutfrom a tube of suitable material by laser cutting, electrical dischargemachining or any other suitable process.

In the event that the filter has remained in the vessel for a longerperiod of time, the primary struts may be overgrown by neovascularovergrowth of the intima layer of the vessel wall. The tendency ofovergrowing of the struts is increased by the spring biasedconfiguration of the struts and the radial outward orientation of theouter end of the struts in relation to the longitudinal axis. Thisresults in the struts dilating the vessel wall along the contact surfaceof the struts with the vessel wall. The intima layer overgrowing thestruts will increase the anchoring of the filter, so the struts willfollow the movements of the wall, and migration of the filter isavoided. Even when the struts are overgrown by intima layer, the filtermay be removed without any substantial damage to the vessel wall. Theintima layer that has overgrown the struts will restrict the pullingforces to act parallel to the wall and thereby pulling the struts outeasily, instead of breaking the overgrown layer. Apart from a small cutcaused by the hook, there will not be any further damage and the cutwill heal in relatively less time whereas tearing of the intima layerwould otherwise take relatively more time to heal.

The filter 10 may be comprised of any suitable material such assuperelastic material or spring material, including but not limited tonitinol, stainless steel wire, cobalt-chromium-nickel-molybdenum-ironalloy, or cobalt-chrome alloy. It is understood that the filter 10 maybe formed of any other suitable material that will result in aself-opening or self-expanding filter, such as shape memory alloys.Shape memory alloys have a property of becoming rigid, i.e., returningto a remembered state, when heated above a transition temperature. Ashape memory alloy suitable for the present invention may comprise Ni—Tiavailable under the more commonly known name Nitinol. When this materialis heated above the transition temperature, the material undergoes aphase transformation from martensite to austenic, such that materialreturns to its remembered state. The transition temperature is dependenton the relative proportions of the alloying elements Ni and Ti and theoptional inclusion of alloying additives.

In one alternate embodiment, the filter 10 may be made from Nitinol witha transition temperature that is slightly below normal body temperatureof humans, which is about 98.6° F. Although not necessarily a preferredembodiment, when the filter 10 is deployed in a body vessel and exposedto normal body temperature, the alloy of the filter 10 will transform toaustenite, that is, the remembered state, which for one embodiment ofthe present invention is the expanded configuration when the filter 10is deployed in the body vessel. To remove the filter 10, the filter 10is cooled to transform the material to martensite which is more ductilethan austenite, making the filter 10 more malleable. As such, the filter10 can be more easily collapsed and pulled into a lumen of a catheterfor removal.

In another alternate embodiment, the filter 10 may be made from Nitinolwith a transition temperature that is above normal body temperature ofhumans, which is about 98.6° F. Although not necessarily a preferredembodiment, when the filter 10 is deployed in a body vessel and exposedto normal body temperature, the filter 10 is in the martensitic state sothat the filter 10 is sufficiently ductile to bend or form into adesired shape, which for the present invention is an expandedconfiguration. To remove the filter 10, the filter 10 is heated totransform the alloy to austenite so that the filter 10 becomes rigid andreturns to a remembered state, which for the filter 10 in a collapsedconfiguration.

While the present invention has been described in terms of preferredembodiments, it will be understood, of course, that the invention is notlimited thereto since modifications may be made to those skilled in theart, particularly in light of the foregoing teachings.

The invention claimed is:
 1. A filter for capturing thrombi in a bloodvessel, the filter comprising: a plurality of struts having a collapsedstate for filter retrieval or delivery and an expanded state forengaging with a vessel wall of the blood vessel, each strut in theexpanded state extending from a first end to a second end, the firstends being attached together along a longitudinal axis of the filter,each strut extending arcuately along the longitudinal axis and includinga proximal portion extending from the first end and a distal portionextending from the proximal portion to the second end, the distalportion of each strut including an anchoring hook configured topenetrate the vessel wall; and a stop member configured to engage thevessel wall to prevent further penetration of the anchoring hook intothe vessel wall, the stop member further being configured to enhancevisualization of the anchoring hook and its position relative to thevessel wall, the stop member consisting of a linear portion being formedseparately from the strut and attached to the strut adjacent theanchoring hook such that the stop member extends distally from the strutand the anchoring hook.
 2. The filter of claim 1, wherein the stopmember extends distally from the anchoring hook a distance in the rangeof about 0.5 mm to about 10.0 mm.
 3. The filter of claim 1, wherein thestop member is attached to the strut by one of welding, soldering, andgluing.
 4. The filter of claim 1, wherein the stop member has a roundeddistal tip so that it is atraumatic to the vessel wall.